Pharma Consultant in Vietnam, Pharmaceutical Consultancy Services in Vietnam
Pharmaceutical Consultancy Services in Vietnam
Micron HVAC Pvt. Ltd.is Pharma Consultant in Vietnam and providing Pharmaceutical Consultancy Services in Vietnam
Core Experience in:
- Designing & qualification of formulation manufacturing facilities
- Manufacturing operations of wide spectrum for formulations
- GMP compliance and regulatory audits.
Core Competency:
- Designing and Operations of:
- Isolator based manufacturing facility for Cytotoxic / high potency injectable formulations, including Lyophilized formulations.
- Manufacturing facility for Aseptic or terminally sterilized Injectable formulations
- Manufacturing facility for Oral Solid dosage forms – Tablets and capsules
- Manufacturing facility for External Preparations (Ointments and Creams)
- Upgradation of existing facilities for GMP compliance and productivity improvements
- Designing of formulation manufacturing facilities
- Preparation of URS for manufacturing facility and equipment
- Preparation of Qualification documents: IQ/OQ/PQ
- Equipment and facility qualification
- Clean Room qualification and designing facility monitoring program
- Developing equipment cleaning processes and Cleaning Validation
- Risk Assessment and risk mitigation
- GMP Training
- Facility Audit and gap identification.
- GMP compliance
- Deviation investigation and root cause identification
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